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Oct. 21, 2014, PLLR E-Newsletter

Courtney L. Davenport

Heeding the call from safety advocates and medical experts, an FDA panel has recommended by a 20-1 vote that the agency tighten control over testosterone replacement therapies (TRTs) to ensure they are prescribed only to men with serious medical conditions. The panel also voted to require that drugmakers perform clinical studies to further test the link between TRTs and heart attacks and strokes.

Heeding the call from safety advocates and medical experts, an FDA panel has recommended by a 20-1 vote that the agency tighten control over testosterone replacement therapies (TRTs) to ensure they are prescribed only to men with serious medical conditions. The panel also voted to require that drugmakers perform clinical studies to further test the link between TRTs and heart attacks and strokes.

TRTs have been approved since the 1950s for men who suffer hypogonadism, a medical condition that causes the body to produce insufficient testosterone. In the last decade, drugmakers have waged a campaign to convince healthy men that the fatigue, weight gain, and decreased sex drive that can naturally occur with aging are the result of low testosterone, or “low T,” and can be treated with TRTs. The campaign worked—by 2013, TRT sales had surpassed those of Viagra. But recent studies have shown a link between TRTs and cardiovascular issues such as heart attacks and strokes.

“This is a classic example of disease mongering,” said New York City attorney David Ratner, who is on the plaintiffs’ steering committee in an MDL against all TRT manufacturers for failing to warn of the risks. “There is no such disease as low T. They created a consumer demand for a product to treat a condition that doesn’t exist, that isn’t life-threatening, and that they say enhances lives of guys, and the consequences of doing that are tragic if we’re right that it causes cardiovascular problems.”

For years, small studies showed a significant increase of cardiovascular events in men taking testosterone, but the studies flew under the radar. In 2010, a safety board halted a study of 209 men after researchers noted a five-fold increase in cardiovascular problems in men receiving a testosterone gel over men receiving a placebo. Other studies have found a two-fold risk increase. Then in November 2013, JAMA published a study finding an increased risk of adverse outcomes for patients in the Veterans Affairs health system who were given testosterone, even if they had been healthier than other patients who did not receive it. Last January, a study evaluating about 55,600 men found that for those 65 and older, the risk of heart attack doubled in the 90 days after they started TRT, and men younger than 65 with a history of heart disease were at a two- to three-fold increased risk. These studies prompted the FDA to initiate a safety investigation.

Last month, an FDA panel comprising the Bone, Reproductive, and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee heard presentations from the FDA, scientists, and TRT sponsors about whether TRTs were being prescribed for the right patients and whether there are cardiovascular risks. Ronald Johnson Jr. of Fort Wright, Ky., who also represents plaintiffs in the MDL, said the FDA seemed reluctant to acknowledge a link between TRTs and cardiovascular events, while the scientists said the link was “concerning” and required further study. But the panel was more animated.

“The committee members were much more accepting of the association between testosterone and cardiovascular injuries, with several of them stating that it was biologically plausible and there was a clear signal,” said Johnson. “The committee members were extremely critical of testosterone being prescribed to men for age-related decline in testosterone levels, as this was not a use approved by the FDA. The panelists were also openly incredulous that the drug was approved at all when there was no evidence of its efficacy.”

Ratner said it’s a good step, but the panel should have issued an immediate warning about the cardiovascular issues, as safety advocates have urged.

“The last three studies that have come out have pointed to strong signals that there is a cardiovascular risk in using TRTs,” he said. “So they should have upped the warning.”

The FDA doesn’t have to take the panel’s recommendations, but it often does. Even if the FDA does clamp down on the therapies’ approved use, however, Johnson and Ratner agree it might not be enough because doctors can still prescribe it for off-label uses.

“I think it will certainly curb prescriptions from primary care physicians and most urologists who were unaware until this point that they were prescribing the drug for an off-label use,” said Johnson. “But I don’t think it will slow down the doctors who have started ‘T-Clinics’ to aggressively promote testosterone as a fountain-of-youth drug for all aging men.”

The MDL includes more than 200 cases against all TRT manufacturers, with the majority of cases against the leading manufacturer, AbbVie Inc. The parties are still in the scheduling phase. (In re Testosterone Replacement Therapy Prods. Liab. Litig., No. 1:14-cv-01748, MDL No. 2545 (N.D. Ill. consol. Mar. 14, 2014).)